Trial · NCT00525265
A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
NCT00525265, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2013-12-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure). Trials, record NCT00525265. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00525265
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
- NCT number
- NCT00525265
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Cardiac Edema
- Interventions
- OPC-41061(Tolvaptan), Placebo
- First posted
- 2007-09-05
- Last updated
- 2013-12-25
- Results first posted
- 2013-12-25
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Body Weight | Baseline, at the time of final trial drug administration | The body weight change from baseline at the time of final trial drug administration |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Body Weight | Baseline, at the time of final trial drug administration | Kg | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Body Weight | OPC-41061 7.5 mg | -1.68 | Standard Deviation 1.83 | Kg | |
| Body Weight | OPC-41061 15 mg | -2.14 | Standard Deviation 1.45 | Kg |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OPC-41061 7.5 mg | 10 | |
| Overall Study | STARTED | OPC-41061 15 mg | 10 | |
| Overall Study | COMPLETED | OPC-41061 7.5 mg | 9 | |
| Overall Study | COMPLETED | OPC-41061 15 mg | 10 | |
| Overall Study | NOT COMPLETED | OPC-41061 7.5 mg | 1 | |
| Overall Study | NOT COMPLETED | OPC-41061 15 mg | 0 |
Source ClinicalTrials.gov
Adverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | OPC-41061 7.5 mg | 0 | 10 | 0 |
| other | Constipation | Gastrointestinal disorders | OPC-41061 15 mg | 1 | 10 | 1 |
| other | Epigastric Discomfort | Gastrointestinal disorders | OPC-41061 7.5 mg | 0 | 10 | 0 |
| other | Epigastric Discomfort | Gastrointestinal disorders | OPC-41061 15 mg | 1 | 10 | 1 |
| other | Vomiting | Gastrointestinal disorders | OPC-41061 7.5 mg | 1 | 10 | 1 |
| other | Vomiting | Gastrointestinal disorders | OPC-41061 15 mg | 0 | 10 | 0 |
| other | Feeling Hot | General disorders | OPC-41061 7.5 mg | 1 | 10 | 1 |
| other | Feeling Hot | General disorders | OPC-41061 15 mg | 0 | 10 | 0 |
| other | Malaise | General disorders | OPC-41061 7.5 mg | 1 | 10 | 1 |
| other | Malaise | General disorders | OPC-41061 15 mg | 0 | 10 | 0 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OPC-41061 7.5 mg | ||
| Total, all-cause mortality | OPC-41061 15 mg | ||
| Total, other adverse events | OPC-41061 7.5 mg | 10 | 10 |
| Total, other adverse events | OPC-41061 15 mg | 9 | 10 |
| Total, serious adverse events | OPC-41061 7.5 mg | 0 | 10 |
| Total, serious adverse events | OPC-41061 15 mg | 1 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| OPC-41061 7.5 mg vs OPC-41061 15 mg: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00525265
GET https://conductscience.org/api/trials/v1/NCT00525265/events?page=2